YAOPHARMA CO LTD FDA Approval ANDA 071061

ANDA 071061

YAOPHARMA CO LTD

FDA Drug Application

Application #071061

Application Sponsors

ANDA 071061YAOPHARMA CO LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL25MG;80MG0PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE

FDA Submissions

ORIG1AP1987-08-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-10-13
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1988-10-13
LABELING; LabelingSUPPL5AP1989-06-27
LABELING; LabelingSUPPL6AP1991-11-25
LABELING; LabelingSUPPL7AP1992-03-26
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1995-03-27
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-12-31
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-12-31
LABELING; LabelingSUPPL11AP1998-09-08
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-05-09
LABELING; LabelingSUPPL15AP2020-08-06STANDARD
LABELING; LabelingSUPPL16AP2020-08-20STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL12Null0
SUPPL15Null7
SUPPL16Null7

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71061
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE","strength":"25MG;80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE","submission":"HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE","actionType":"25MG;80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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